drugset / Trial / NCT05607615
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Approximately 90 patients, aged 50 to 80 years, with a diagnosis of early Alzheimer's disease will take part in this research study. This study will be conducted in the US. There will be 3 treatment groups: 2 Active doses and 1 group will receive placebo completely by chance. Patients, caregiver, Sponsor, nor study staff will know which treatment is assigned. There are 3 periods in this study: Screening to confirm suitability, Treatment to receive study medication, and Follow-up to check overall health post-participation
Timeline
- Start
- 2022-09-23
- Primary completion
- 2024-03-31
- Completion
- 2024-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 2-hydroxypropyl-beta-cyclodextrin | Unknown | 500 mg/kg | Intravenous |
| Subject | 2-hydroxypropyl-beta-cyclodextrin | Unknown | 1000 mg/kg | Intravenous |